THD Slide One
FDA 510(k) K090009 · Thd Spa
510(k) numberK090009
Submission
- Device name
- THD Slide One
- Applicant
- Thd Spa
North Reading, MA, US - Received
- January 2, 2009
- Decision date
- January 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K141657 | THD RevolutionJAF · Traditional | Thd Spa | 02/24/2015SE |
| K110628 | SimpleabiJAF · Traditional | Newman Medical | 05/12/2011SE |
| K093393 | Lifedop Model 300ABIJAF · Traditional | Summit Doppler Systems, Inc. | 12/24/2009SE |
| K081429 | THD SlideJAF · Traditional | Thd Spa | 07/30/2008SE |
| K070815 | THDJAF · Traditional | G.F. S.R.L. | 06/20/2007SE |
| K063600 | Vista AvsJAF · Traditional | Summit Doppler Systems, Inc. | 12/19/2006SE |
| K060064 | StethofluxJAF · Traditional | Odvi | 04/10/2006SE |
| K052067 | Doppler Guided Proctoscope, Model 500HJAF · Traditional | Multigon Industries, Inc. | 08/29/2005SE |
| K010521 | Nicolet VersalabJAF · Special | Nicolet Biomedical | 03/09/2001SE |
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Questions and answers
When was THD Slide One cleared by the FDA?
THD Slide One (K090009) received a 510(k) decision of Substantially Equivalent on January 28, 2009, 26 days after the submission was received.
What is the product code of K090009?
The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.